On May 2, 2016, NCATS held a workshop for Clinical and Translational Science Awards (CTSA) Program representatives and other innovators in clinical research management to educate them about using its new single institutional review board (IRB) reliance platform for multisite clinical studies. The NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Reliance Platform is based on the successful experiences of NIH single IRB initiatives and on CTSA Program demonstration projects using a model called IRBrely. Designed to be a flexible platform that will enable harmonization and streamlining of processes, the NCATS SMART IRB Reliance Platform will be a key component of NCATS’ Trial Innovation Network. In addition, NCATS intends for the platform to serve as a roadmap for the nation to help implement NIH’s policy on single IRB use in multisite studies and as a resource for clinical researchers who conduct these studies.
Nearly 300 people participated in the workshop on the NIH campus in Bethesda, Maryland. The workshop’s goals were to:
- Educate participants about the concept of a single IRB reliance approach;
- Update participants on the progress made on the NCATS SMART IRB Reliance Platform;
- Describe future plans to develop the NCATS SMART IRB Reliance Platform; and
- Define expectations for CTSA Program participants to use the platform.
During the event, NIH staff and CTSA Program collaborators discussed single IRB implementation and some of the draft resources for the NCATS SMART IRB Reliance Platform, including authorization and joinder agreements, standard operating procedures, and best practices for implementing the resources. Participants included representatives from each CTSA Program hub, including investigators who will lead the Trial Innovation Network at each hub, IRB administrators, project managers and study coordinators, as well as individuals from other NIH Institutes, Centers and Offices. One key outcome was that stakeholders were able to discuss and address challenges and opportunities for the platform.
Updated May 2016